Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    shr-1314 | psoriasis
Previous Study | Return to List | Next Study

A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121143
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE September 27, 2019
First Posted Date  ICMJE October 9, 2019
Last Update Posted Date October 9, 2019
Estimated Study Start Date  ICMJE October 30, 2019
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
Proportion of subjects reach to PASI 75 response at 16 weeks [ Time Frame: 16 week ]
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 75% (to achieve a PASI 75 response) relative to the baseline PASI score at Week 16
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2019)
Proportion of subjects achieving PASI 90 response at week 16 [ Time Frame: 16 week ]
Proportion of subjects with a Psoriatic Area and Severity Index (PASI) score improved by at least 90% (to achieve a PASI 90 response) relative to the baseline PASI score at Week 16 will be evaluated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of SHR-1314 Injection in the Treatment of Moderate to Severe Plaque Psoriasis in Adults
Official Title  ICMJE Multicenter, Placebo-controlled, Parallel-randomized, Double-blind, Phase II Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of SHR-1314 Injection With Moderate to Severe Plaque Psoriasis in Adults
Brief Summary This is a multicenter, placebo-controlled, parallel-randomized, double-blind, phase II study to investigate the efficacy, safety, tolerability and Pharmacokinetics of SHR-1314 injection with moderate to severe plaque psoriasis in adults
Detailed Description This study was a multicenter, parallel, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy ,safety, tolerance, and pharmacokinetics (PK) of different SHR-1314 dosing regimens in moderate to severe chronic plaque psoriasis in adults.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Biological: IL-17A Antagonist
    SHR-1314 subcutaneous injection
    Other Name: SHR-1314
  • Biological: Placebos
    placebo subcutaneous injection to maintain consistency and to prevent blindness
Study Arms  ICMJE
  • Active Comparator: Treatment group A
    SHR-1314 low dose short intervals of subcutaneous injection
    Intervention: Biological: IL-17A Antagonist
  • Active Comparator: Treatment group B
    SHR-1314 high dose long intervals of subcutaneous injection
    Interventions:
    • Biological: IL-17A Antagonist
    • Biological: Placebos
  • Active Comparator: Treatment group C
    SHR-1314 high dose short intervals of subcutaneous injection
    Interventions:
    • Biological: IL-17A Antagonist
    • Biological: Placebos
  • Placebo Comparator: Placebo group
    Placebo was subcutaneously injected into the 16 weeks turnover SHR-1314 subcutaneous injection
    Interventions:
    • Biological: IL-17A Antagonist
    • Biological: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 8, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • Inclusion Criteria:
  • Provide written informed consent before any study assessment is performed.
  • Male or female at least 18 years of age at screening.
  • Chronic plaque psoriasis history ≥ 6 months;At the time of randomization, moderate to severe plaque psoriasis.
  • Subject is a candidate for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy.
  • The body mass index (BMI) was ≥18 kg/m2 and ≤35 kg/m2 at screening.
  • Exclusion Criteria:
  • Diagnosis of psoriasis at screening is not chronic plaque psoriasis
  • Severe infection or systemic infection before baseline
  • There are other skin problems that researchers believe will hinder the evaluation of psoriasis.
  • Subject has a history or symptom of malignancy within 5 years prior to screening, regardless of whether or not treatment has been received, with or without signs of recurrence or metastasis.
  • The investigators believe that the subject is not suitable for any clinical condition involved in the clinical study.
  • Those who are allergic to the study ingredients or excipients, or who are allergic to other biological agents.
  • There is evidence that hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) confirmation test is positive.
  • Subject's medical history, symptoms and examination results suggest active tuberculosis or latent tuberculosis.
  • Laboratory tests have clinical implications at screening, and the investigators believe that participation in the study may pose unacceptable risks to the subject or impede data analysis.
  • Women who are pregnant or breastfeeding at screening or at baseline
  • The investigator believes that it will prevent the subject from following and completing any other circumstances of the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qian Xu, Ph.D +86051881220000 xuqian@hrglobe.cn
Contact: Jianwen Chen, Ph.D
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04121143
Other Study ID Numbers  ICMJE SHR-1314-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP